Legal questions stall consolidation plan

WASHINGTON - Plans to consolidate reviews of applications to conduct gene therapy trials are in a state of suspended animation pending the outcome of efforts by FDA and NIH lawyers to find a legal way to implement them.

The NIH's Recombinant DNA Advisory Committee approved the consolidation at a meeting two weeks ago. The consolidation would dramatically speed approval of many gene therapy trial applications, especially for trials involving well-known vectors and populations, according to Sheryl Osborne, director of regulatory affairs at Viagene Inc...